Drug Brand Name

PA Status

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.

*

The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.

II. Therapeutic Uses

FDA-approved, for example:

Bile acid synthesis disorders due to single enzyme defects with or without familial hypertriglyceridemia (Cholbam)

III. Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

All PA requests must include clinical diagnosis, drug name, dose, and frequency.

A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.

For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.

Align, Culturelle, Florastor ≥ 19 years

Documentation of the following is required for the diagnosis of antibiotic associated diarrhea (prophylaxis):

appropriate diagnosis; and

inadequate response or adverse reaction within the last 90 days to two of the following or contraindication to all of the following: alosetron, bismuth subsalicylate, diphenoxylate/atropine, loperamide; and

current antibiotic therapy.

Documentation of the following is required for the diagnosis of bacterial overgrowth:

appropriate diagnosis; and

treatment for at least seven days within the last 90 days with one of the following: amoxicillin-clavulanic acid, chloramphenicol, ciprofloxacin, metronidazole, tetracycline, trimethoprim-sulfamethoxazole, rifaximin.

Documentation of the following is required for the diagnosis of chronic constipation:

appropriate diagnosis; and

inadequate response or adverse reaction to three of the following or contraindication to all of the following: docusate, fiber supplementation/bulk-forming laxatives, lubiprostone or linaclotide, osmotic laxatives, saline laxatives, stimulant laxatives.

Documentation of the following is required for the diagnosis of C. difficile associated diarrhea:

appropriate diagnosis; and

inadequate response or adverse reaction within the last 90 days to one of the following or contraindication to all of the following: fidaxomicin, metronidazole, rifaximin, oral vancomycin.

Documentation of the following is required for the diagnosis of irritable bowel syndrome associated with constipation (IBS-C):

appropriate diagnosis; and

inadequate response or adverse reaction to two of the following or contraindication to all of the following: docusate, fiber supplementation/bulk-forming laxatives, lubiprostone or linaclotide, osmotic laxatives, saline laxatives, stimulant laxatives.

Documentation of the following is required for the diagnosis of irritable bowel syndrome associated with diarrhea (IBS-D):

appropriate diagnosis; and

inadequate response or adverse reaction to two of the following or contraindication to all of the following: antibiotic (rifaximin), anti-diarrheal, antispasmodic, bile acid sequestrant, tricyclic antidepressant (TCA).

Documentation of the following is required for the diagnosis of recurrent vaginitis:

appropriate diagnosis; and

inadequate response or adverse reaction within the last 90 days to two of the following or contraindication to all of the following: butoconazole, clindamycin, clotrimazole, fluconazole, metronidazole, miconazole, terconazole.

alosetron

Documentation of the following is required:

appropriate diagnosis; and

member must be a female ≥ 18 years of age; and

prescriber is a gastroenterologist or has documented a consultation with a gastroenterologist; and

inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk forming laxatives, osmotic laxatives, saline laxatives,stimulant laxatives).

chenodiol

Documentation of the following is required:

appropriate diagnosis; and

member is ≥ 3 weeks of age; and

member's current weight.

Cholbam

Documentation of the following is required:

appropriate diagnosis; and

inadequate response, adverse reaction, or contraindication to an ursodiol product; and

member's current weight.

Clenpiq, Plenvu, Suprep

Documentation of the following is required:

inadequate response or adverse reaction to one polyethylene glycol product available without PA; or

medical necessity for product.

SmartPA: Claims for Clenpiq, Plenvu, and Suprep will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for one polyethylene glycol product available without PA.†

Gattex

Documentation of the following is required:

appropriate diagnosis; and

member is ≥ 18 years of age; and

dependence on parenteral nutrition or intravenous fluids for at least one year; and

Linzess

inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk forming laxatives, osmotic laxatives, saline laxatives,stimulant laxatives).

Motegrity, Movantik, Symproic, Trulance

Documentation of the following is required:

appropriate diagnosis; and

member is ≥ 18 years of age; and

quantity does not exceed 30 tablets/month; and

inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk forming laxatives, osmotic laxatives, saline laxatives,stimulant laxatives); and

Mytesi

inadequate response, adverse reaction, or contraindication to two of the following: loperamide, bismuth subsalicylate, or diphenoxylate/atropine; and

quantity does not exceed 60 tablets/30 days.

Ocaliva

Documentation of the following is required:

appropriate diagnosis of primary biliary cholangitis supported by laboratory testing results and medical records documenting two of the following:

alkaline phosphatase elevation

presence of antimitochondrial antibody

histopathologic evidence of cholangitis and destruction of small or medium-sized bile ducts on biopsy, if performed; and

member is ≥ 18 years of age; and

one of the following:

alkaline phosphatase > upper limit of normal; or

total bilirubin > upper limit of normal; and

one of the following:

inadequate response to ursodiol at a dose of 13 to 15 mg/kg/day for at least one year and request is for use with ursodiol 13 to 15 mg/kg/day; or

adverse reaction or contraindication to ursodiol; and

quantity does not exceed 30 units/30 days; and

one of the following:

request is for initiation of treatment and requested dose is 5 mg once daily (Child-Pugh Class A) or once weekly (Child-Pugh Class B or C); or

request is for continuation of treatment beyond three months and both of the following:

if request is for continuation of treatment beyond 12 months, one of the following:

if alkaline phosphatase was > upper limit of normal at baseline, alkaline phosphatase < 1.67-times upper limit of normal; or

≥ 15% decrease in alkaline phosphatase; or

if total bilirubin was > upper limit of normal at baseline, total bilirubin ≤ upper limit of normal; or

clinical rationale for continued treatment; and

one of the following:

requested dose is 10 mg once daily; or

requested dose and/or frequency is less than 10 mg once daily and one of the following:

positive response to therapy at current dose (defined as alkaline phosphatase < 1.67-times upper limit of normal, total bilirubin ≤ upper limit of normal, and ≥ 15% decrease in alkaline phosphatase); or

Child Pugh Class B or C; or

clinical rationale for not titrating the dose to 10 mg once daily.

opium tincture

Documentation of the following is required:

diagnosis of chronic diarrhea; and

member is ≥ 18 years of age; and

inadequate response, adverse reaction, or contraindication to two of the following agents: loperamide, bismuth subsalicylate, or diphenoxylate/atropine.

Relistor

Documentation of the following is required for diagnosis of opioid induced constipation with advanced illness receiving palliative care:

appropriate diagnosis; and

member is ≥ 18 years of age; and

inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk forming laxatives, osmotic laxatives, saline laxatives,stimulant laxatives).

Documentation of the following is required for diagnosis of opioid induced constipation with chronic non-cancer pain:

appropriate diagnosis; and

member is ≥ 18 years of age; and

inadequate response, adverse reaction, or contraindication to one agent from three of the four traditional laxative therapy classes (bulk forming laxatives, osmotic laxatives, saline laxatives,stimulant laxatives); and

inadequate response, adverse reaction, or contraindication to Movantik; and

one of the following:

inadequate response or adverse reaction to Linzess or Amitiza; or

contraindication to both Linzess and Amitiza.

Viberzi

Documentation of the following is required:

appropriate diagnosis; and

member is ≥ 18 years of age; and

prescriber is a gastroenterologist or has documented a consultation with a gastroenterologist; and

medication will be used in combination with an antibiotic being used for the treatment of Clostridium difficile infection including at least one of the following:

metronidazole; or

vancomycin; or

fidaxomicin; or

rifaximin.

†Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.